Status:
ACTIVE_NOT_RECRUITING
Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
Carlos III Health Institute
Conditions:
Chronic Post-surgical Pain
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The clinical trial will be conducted in 14 Spanish hospitals. It is estimated, based on our previous studies, that 2855 patients scheduled for elective inguinal hernia surgery will have to be assessed...
Detailed Description
Prospective, multicenter, double-blind randomized double-blind controlled trial. In the first phase the investigators use the Chronic Post-Surgical Pain (CPSP) risk model to select patients scheduled ...
Eligibility Criteria
Inclusion
- Men resident in Spain who are scheduled for open inguinal hernia repair (inpatient or outpatient procedures).
- Risk of post-surgical pain chronification \> 27% using the GENDOLCAT risk scale.
Exclusion
- Age under 18 years
- Patients who in the recruiter's opinion have insufficient knowledge of Spanish to understand the trial
- Patients who are currently being treated with duloxetine
- Patents with known allergy to duloxetine
- Serious renal failure (creatinine clearance \>30 ml/min)
- Patients requiring reoperation because of surgical complications
- Transplanted patients
- History of coronary artery disease, including previous myocardial infarction, angina, percutaneous transluminal coronary angioplasty
- History of congestive heart failure
- Currently taking a monoamine oxidase inhibitor or other medication with substantial interaction with duloxetine
- Antidepressant use within 4 weeks of study start
- Treatment with inhibitors of cytochrome P450 mixed-function oxidase system (CYP1A2): fluvoxamine, ciprofloxacin or enoxacin
- Uncontrolled hypertension
- Bipolar disorder
- History of seizures
- Elevated intraocular pressure or risk of acute glaucoma
- Treatment with selective serotonin reuptake inhibitors (SSRIs)
- Treatment with serotonin and noradrenaline reuptake inhibitors (SNRIs)
- Treatment with tricyclic antidepressants
- Treatment with triptans
- Treatment with antipsychotic drugs
- Treatment with dopamine antagonists
- Treatment with oral anticoagulant agents
- Treatment with Hypericum perforatum
- Major depression disorder
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT06606067
Start Date
September 3 2024
End Date
December 31 2026
Last Update
September 20 2024
Active Locations (1)
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1
Hospital del Mar
Barcelona, Spain, 08003